Refining growth intervention targets: percentilebased efficacy analysis of fermented oyster extract (FGO) in pediatric short stature
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This research presents a secondary evaluation of data from a previously conducted randomized, double-blind, placebo-controlled trial investigating the potential of fermented oyster extract (FGO) to enhance linear growth in children aged 6–11 years diagnosed with idiopathic or constitutional short stature. A total of 100 subjects with heights below the 25th percentile were randomly allocated to receive either 500 mg of FGO or a placebo daily over a 24-week period. The principal measure of efficacy was increase in stature, with secondary assessments including height velocity (HV), height standard deviation scores (SDS), bone age (BA), growth-related hormones (growth hormone, insulin-like growth factor 1 [IGF-1], and insulin-like growth factor-binding protein 3 [IGFBP-3]), bone metabolism indicators (deoxypyridinoline, osteocalcin), luteinizing hormone (LH), and safety metrics. The per-protocol analysis encompassed 93 participants (experimental group [EG], n = 46; control group [CG], n = 47). The EG demonstrated a statistically significant greater increase in height compared with the CG (4.10 ± 1.57 cm vs. 2.94 ± 0.73 cm; p < 0.001). Subgroup assessments indicated the most pronounced effects in children within the 3rd to 25th percentiles, where the height difference between groups reached 1.23 cm (p < 0.001). Both HV and SDS exhibited meaningful improvements in the EG across all percentiles analyzed. Although IGF-1 levels showed similar reductions in both groups, IGFBP-3 levels were more consistently maintained in the EG (p = 0.019), indicating the possibility of enhanced IGF-1 bioactivity. BA measurements and bone turnover markers remained within expected ranges, and no severe adverse reactions were reported. These outcomes suggest FGO could be a safe and effective nutritional strategy for stimulating height increase in children with mild forms of short stature. Future investigations should consider exploring potential sex-specific responses and detailed hormonal pathways underlying these effects.
Abstract
This research presents a secondary evaluation of data from a previously conducted randomized, double-blind, placebo-controlled trial investigating the potential of fermented oyster extract (FGO) to enhance linear growth in children aged 6–11 years diagnosed with idiopathic or constitutional short stature. A total of 100 subjects with heights below the 25th percentile were randomly allocated to receive either 500 mg of FGO or a placebo daily over a 24-week period. The principal measure of efficacy was increase in stature, with secondary assessments including height velocity (HV), height standard deviation scores (SDS), bone age (BA), growth-related hormones (growth hormone, insulin-like growth factor 1 [IGF-1], and insulin-like growth factor-binding protein 3 [IGFBP-3]), bone metabolism indicators (deoxypyridinoline, osteocalcin), luteinizing hormone (LH), and safety metrics. The per-protocol analysis encompassed 93 participants (experimental group [EG], n = 46; control group [CG], n = 47). The EG demonstrated a statistically significant greater increase in height compared with the CG (4.10 ± 1.57 cm vs. 2.94 ± 0.73 cm; p < 0.001). Subgroup assessments indicated the most pronounced effects in children within the 3rd to 25th percentiles, where the height difference between groups reached 1.23 cm (p < 0.001). Both HV and SDS exhibited meaningful improvements in the EG across all percentiles analyzed. Although IGF-1 levels showed similar reductions in both groups, IGFBP-3 levels were more consistently maintained in the EG (p = 0.019), indicating the possibility of enhanced IGF-1 bioactivity. BA measurements and bone turnover markers remained within expected ranges, and no severe adverse reactions were reported. These outcomes suggest FGO could be a safe and effective nutritional strategy for stimulating height increase in children with mild forms of short stature. Future investigations should consider exploring potential sex-specific responses and detailed hormonal pathways underlying these effects.